FDA.reportPublic FDA data

NA

Primary DI
03700879509723
Brand
NA
Company
NOVASTEP
Model
XMS01018
Catalog number
XMS01018
Device description
E-Wedge sizer 6
Published
2019-12-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700879509723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700879509723037008795097233700879509723

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33299338650contact@novastep-ortho.com

Regulatory Flags#

DUNS number
264255288
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700879518565PECAPLASTY®ACC1025P0001ACC1025P00012026-03-19
03700879518572PECAPLASTY®ACC1025P0002ACC1025P00022026-03-19
03700879518589PECAPLASTY®XMS01055-1XMS01055-12026-03-19
03700879518596PECAPLASTY®XMS01055-2XMS01055-22026-03-19
03700879516479arcad® 2.0CSK101012CSK1010122024-08-08
03700879516486arcad® 2.0CSK121212CSK1212122024-04-16
03700879516493arcad® 2.0CSK151515CSK1515152024-04-16
03700879516509arcad® 2.0CSK181818CSK1818182024-04-16
03700879516516arcad® 2.0CSK202020CSK2020202024-04-16
03700879516523arcad® 2.0CSK252020CSK2520202024-04-16
03700879516530arcad® 2.0CSK261818CSK2618182024-04-16
03700879516547arcad® 2.0CSK302020CSK3020202024-04-16
03700879516554arcad® 2.0CSK301612CSK3016122024-04-16
03700879500386arcad®CS010909CS0109092015-10-16
03700879500393arcad®CS011214CS0112142015-10-16
03700879500409arcad®CS011416CS0114162015-10-16
03700879500416arcad®CS011518CS0115182015-10-16
03700879501239arcad®CS020808CS0208082015-10-16
03700879501246arcad®CS031212CS0312122015-10-16
03700879501253arcad®CS031414CS0314142015-10-16

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Primary DI, Brand, Company table
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